DEMEDIOX

Report

Report Number: 3007895168-2024-00020
Event Type: Injury
Date Received: November 29, 2024
Report Date: June 11, 2024
Manufacturer: DEMETECH CORPORATION
Product Code: NEW
UDI-DI: 10652927668251
PMA / PMN Number: K082097
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

TWO PRODUCTS USED IN THE SAME PROCEDURE: PRODUCT 1: MDR 3007895168-2024-00012 BLUNT BARB 4 - 21G X 2 1/2" LOT DW1C-4DA2160230104 EXPIRATION DATE: 01/16/2024 PRODUCT 2: MDR 3007895168-2024-00020 BLUNT SMOOTH - 29G X 1" LOT U103-22 EXPIRATION DATE 10/01/2025.

Description of Event or Problem · 0

ON JUNE 11TH, 2024, THE PATIENT CONTACTED NOVATHREADS DIRECTLY OVER EMAIL EXPLAINING HER CONCERNS ABOUT THREADS IMPLANTED ON HER OVER A YEAR AGO. PATIENT WAS CLAIMING THAT THE THREADS PUT HER IN THE ICU AS WELL AS OTHER PATIENTS IN THE OFFICE (SHE WAS A FORMER EMPLOYEE AT (B)(6)). SHE CLAIMS TO HAVE DOCUMENTATION THAT SHOWS THAT THE THREADS ARE NOT SAFE. SHE STATES THAT IF NOTHING IS DONE, SHE WILL FILE A LAWSUIT DUE TO THE DAMAGES AND HARM IT CAUSED HER. SHE CLAIMS TO TAKE THIS TO THE NEWS IF NOVATHREADS DOES NOT REPLY WITH A SOLUTION. ON JUNE 11TH, 2024, NOVATHREADS CONTACTED THE PATIENT OVER EMAIL REQUESTING THE PROVIDER CONTACT INFORMATION TO INITIATE AN INVESTIGATION. PATIENT REPLIED WITH CONTACT INFORMATION AND PROVIDED PICTURES AND VIDEOS OF HER PROCEDURE. ACCORDING TO THE PATIENT, SHE WOKE UP THE FOLLOWING DAY AFTER THE PROCEDURE WITH HER FACE AS DEMONSTRATED IN THE PICTURES PROVIDED. PICTURES SHOW SWELLING/BUMPS ON THE FACE AND BRUISING UNDER THE CHIN (NECK AREA). PATIENT STATED THAT SHE WENT STRAIGHT TO THE CUSTOMER'S OFFICE. THE NURSE PRACTITIONER WOULD NOT SEE HER AND HAD HER SISTER (NURSE INJECTOR/RN) SEE THE PATIENT. THE NURSE PRACTITIONER TOLD THE NURSE INJECTOR TO TELL THE PATIENT IT WAS TISSUE TRAUMA AND SENT IN PREDNISONE. THE PATIENT REPORTED THAT EVERY MONTH SINCE SHE HAS BECOME SICKER WITH FLU-LIKE SYMPTOMS AND HER THROAT FELT LIKE SHARDS OF GLASS. THE PATIENT'S PRIMARY DOCTOR COULDN'T FIND OUT WHY. ON MAY 6TH, 2024, THE PATIENT STATED THAT SHE WAS OUTSIDE IN THE HEAT AND STARTED TO FEEL HER THROAT FEELING LIKE GLASS AGAIN. THE PATIENT STATES THAT THEY WENT INTO THE ICU. PATIENT ALSO REPORTED TO HAVE DOCUMENTATION FROM THE HOSPITAL AND FROM THE ICU DOCTOR. THE PATIENT CLAIMS THAT THE PDO THREADS WERE THE CAUSE OF A LIFE-THREATENING INCIDENT WHICH HAS NOT BEEN CONFIRMED. ACCORDING TO THE PATIENT, HER PRIMARY CARE DOCTOR THAT SHE FOLLOWED UP WITH REVIEWED EVERYTHING AND ALSO AGREED. PATIENT REPORTED THAT WHILE SHE WAS IN THE ICU, SHE REACHED OUT TO THE CUSTOMER AND WAS TOLD THE NURSE PRACTITIONER WAS UNAVAILABLE. PATIENT TOLD THE EMPLOYEE ON THE PHONE THAT THIS WAS A LIFE-THREATENING EMERGENCY. THE NURSE PRACTITIONER NEVER REACHED OUT OR RETURNED THE PATIENT'S CALLS. THE PATIENT CLAIMS THAT THE NURSE PRACTITIONER BLOCKED HER SO SHE COULDN'T CONTACT HER. ACCORDING TO THE PATIENT, SHE DID NOT RECEIVE ANY POST-CARE TREATMENT. THE THREADS THE NURSE PRACTITIONER WAS DOING WOULD NOT ANCHOR INTO HER FACE CAUSING DISCOMFORT. THE NURSE PRACTITIONER SAID THIS WAS NORMAL AND KEPT GOING UNTIL SHE GOT THEM IN. PATIENT STATED HER FACE HAS STILL NOT HEALED OVER A YEAR LATER. THE PATIENT IS SEEKING OUT A PLASTIC SURGEON WHO CAN ATTEMPT TO REMOVE THESE THREADS. PATIENT'S DOCTOR IN ICU SAID IF THEY WERE TO USE A LASER TREATMENT IT WOULD MELT INTO THE PATIENT'S SKIN SENDING HER BACK INTO THE HOSPITAL. PATIENT NEEDS ANSWERS ON HOW TO REMOVE THESE FROM HER FACE. ON (B)(6) 2024, THE PATIENT WAS INFORMED THAT WE RECEIVED THE INFORMATION AND WILL CONTACT THE PRACTICE SO THAT THEY CAN PROVIDE ASSISTANCE TO THE PATIENT. PATIENT STATED THAT THE CUSTOMER HAS NOT CONTACTED HER AND THE NURSE PRACTITIONER HAS PERSONALLY BLOCKED HER ON SOCIAL MEDIA. PATIENT DOES NOT FEEL THAT THE CUSTOMER IS TAKING THIS SERIOUSLY. PATIENT CLAIMS TO HAVE AN ACTIVE INFECTION (GREEN PUSS COMING OUT OF THE FACE) FROM THE THREADS. PATIENT IS WONDERING HOW LONG SHE IS TO WAIT FOR THE CUSTOMER TO CONTACT HER. ON JUNE 13TH, 2024, NOVATHREADS CONTACTED THE CUSTOMER. ON JUNE 13TH, 2024, PATIENT CONTACTED NOVATHREADS STATING THAT IT HAS BEEN TWO DAYS AND HAS NOT HEARD ANY CONTACT FROM THE CUSTOMER. THE PATIENT WAS ASKED TO CALL NOVATHREADS WHICH IT WAS EXPLAINED TO THE PATIENT THAT WE CANNOT PROVIDE ANY MEDICAL ADVICE. PATIENT WOULD HAVE TO CONTACT THE PROVIDER WHO PERFORMED THE PROCEDURE TO SEE ASSISTANCE. ON JUNE 13TH, 2024, PROVIDER WAS CONTACTED BY NOVATHREADS TO INITIATE THE INVESTIGATION WHO CONTRIBUTED WITH THE INFORMATION BELOW: THE CUSTOMER STATED THAT THE PATIENT WAS A FORMER DISGRUNTLED EMPLOYEE AT THE PRACTICE. ACCORDING TO THE CUSTOMER, THE PATIENT WAS UPSET THAT THEY WOULD NOT REHIRE HER. PATIENT WAS BEING SEEN FOR KIDNEY STONES AT THE PRACTICE AND WAS EXPERIENCING PAIN AND NAUSEA ON (B)(6) 2023. THE PATIENT WAS UPSET WITH THE CUSTOMER BECAUSE THEY WOULDN'T PRESCRIBE HER MEDICATION TO ADMINISTER HERSELF AT HOME. PATIENT WAS SEEN TWICE FOR JEUVEAU USING HER REGULAR PATTERN APPROVED BY THE HCP. THE PATIENT WAS ALSO UPSET WITH THE SCHEDULING AVAILABILITY ONLINE WITH THE NURSE INJECTOR. THE WRITTEN STATEMENT OF RECOLLECTION OF EVENTS FROM THE NURSE INJECTOR AND THEIR TEXT CONVERSATION WERE PROVIDED BY THE CUSTOMER. PATIENT WAS POSTING ON THEIR SOCIAL MEDIA PAGE AND BECAME IRATE. HCP REPORTED THAT THE PROCEDURE WAS PERFORMED OVER A YEAR AGO WITH TWO VISITS: (B)(6) 2023 AND (B)(6) 2023. THREADS WERE NEVER REMOVED. PRODUCTS USED IN THE PROCEDURE REPORTED BY THE HCP: BLUNT BARB 4 - 21G X 2 1/2" LOT DW1C-4DA2160230104 EXPIRATION DATE: 01/16/2024 BLUNT SMOOTH - 29G X 1" LOT U103-22 EXPIRATION DATE 10/01/2025. HCP WAS OFFERED MEDICAL ADVICE FROM THE MEDICAL DIRECTOR WHICH THEY DECLINED THE OFFER. HCP STATED THAT THE PATIENT CLAIMED TO BE IN THE ICU, BUT THE PATIENT'S MOTHER DISCLOSED THAT THE PATIENT WENT TO THE EMERGENCY DEPARTMENT OF RECTAL BLEEDING FOR COLONOSCOPY AND WAS SENT HOME. THE CUSTOMER ALSO REPORTED THAT THE PATIENT HAS A HISTORY OF BUTT IMPLANTS WITH SURGICAL THREADS SO NO ALLERGY HISTORY. NOVATHREADS REPLIED TO THE CUSTOMER INFORMING THEM THAT THE PATIENT HAS EMAILED NOVATHREADS AND SHE WANTS A RESOLUTION ON THE MATTER REGARDING THE THREADS. THE CUSTOMER WAS NOTIFIED THAT THE PATIENT NEEDS TO GET IN CONTACT WITH THE CUSTOMER TO RESOLVE THIS MATTER OVER THE PHONE OR ON A SCHEDULED VISIT. HCP REPLIED THAT IT IS A STICKY SITUATION, AND THAT THE PATIENT HAS POSTED ON NUMEROUS OCCASIONS ON SOCIAL MEDIA AND HAD TO GET A LAWYER TO INTERVENE. THE THREADS WERE DONE A YEAR AGO. ON JUNE 17TH, 2024, ACCORDING TO THE CUSTOMER, PATIENT WAS POSTING THE CORRESPONDENCE BETWEEN NOVATHREADS AND HERSELF ON THE CUSTOMER'S SOCIAL MEDIA (FACEBOOK). THE CUSTOMER STATED THAT THEY ARE HIRING A LAWYER TO ADDRESS THESE POSTINGS AND ASKED FOR A COPY OF THE CORRESPONDENCE BETWEEN NOVATHREADS AND THE PATIENT. ON JUNE 25TH,2024, THE CUSTOMER WAS OFFERED MEDICAL ADVICE FROM THE MEDICAL DIRECTOR A SECOND TIME VIA EMAIL. ON JUNE 26TH, 2024, NOVATHREADS ATTEMPTED TO CALL THE CUSTOMER, BUT THEY WERE NOT AVAILABLE. ON JUNE 27TH, 2024, NOVATHREADS CONTACTED THE CUSTOMER OVER THE PHONE. THE CUSTOMER DECLINED THE OFFER FOR MEDICAL ADVICE AND THE NURSE PRACTITIONER DISCLOSED THAT THEY HAVE NOT USED ANY OUTDATED THREADS ON THE PATIENT. SHE ALSO MENTIONED THAT THE LAST CONTACT WITH THE PATIENT WAS A YEAR AGO. THE NURSE PRACTITIONER EXPLAINED THAT THE PATIENT WAS A FORMER COWORKER WHO HAD BEEN TERMINATED DUE TO DRUG USE, AND SHE EXPRESSED THAT THIS MATTER IS BEING HANDLED BY THEIR LAWYER, REQUESTING THAT THE COMPLAINT BE CLOSED AS THEY DO NOT INTEND TO HAVE ANY FURTHER CONTACT WITH THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2617977	DEMEDIOX	ABSORBABLE POLYDIOXANONE SURGICAL SUTURE	NEW	DEMETECH CORPORATION	PX4X4086025A16S	U103-22	10652927668251

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female	Other	PREDNISONE